Neladalkib

iStock, beast01 Jideytro is GSK’s first approved product for lung cancer. With its takeover of Nuvalent Bio last month and a deal with Hansoh Pharmaceutical in 2023, the pharma now has several other lung cancer assets in late-stage development. The FDA has signed off on GSK’s ROS1 inhibitor zidesamtinib, one of the main bounties from its recent multibillion buy of Nuvalent Bio, for certain types of lung cancer. The drug will carry the brand name Jideytro. Jideytro is indicated for patients with advanced non-small cell lung cancer (NSCLC) who are positive for the ROS1 gene fusion —a particular mutation that triggers uncontrolled cell growth—and who have undergone a prior line of ROS1-directed therapy. The regulatory win represents GSK’s market entry into lung cancer, according to a Wednesday announcement . The approval also delivers a quick return on GSK’s $10.6 billion acquisition of Nuvalent Bio, which was announced in June and closed last week . The buyout is among the industry’s largest of the year so far. In addition to zidesamtinib, the acquisition gave GSK the ALK blocker neladalkib. That asset is currently under FDA review for NSCLC, with an approval decision expected by Nov. 27 . ezstandalone.cmd.push(function () { ezstandalone.showAds(129); }); Jideytro—and neladalkib, if approved—both have “multi-blockbuster potential,” GSK said in its news release announcing the Nuvalent deal back in June. Around 50,000 people globally are diagnosed with ROS1-positive NSCLC every year, the pharma added on Wednesday, many of whom are non-smokers in middle-age “who could stay on treatment for several years.” Mergers & acquisitions GSK pays $10.6B for cancer biotech Nuvalent in industry’s second-biggest buy of the year Nuvalent Bio is GSK’s third big-ticket purchase this year, after the pharma dropped $2.2 billion in January for RAPT Therapeutics and $950 million in February for 35Pharma. June 9, 2026 · 2 min read · Tristan Manalac Read more Data from the Phase 1/2 single-arm ARROS-1 clinical trial supported Jideytro’s approval, demonstrating an overall response rate of 44%. Duration of response rate was 82% at six months and 69% at 12 months. The drug showed “meaningful and durable responses” even in Patients with brain metastases and ROS1 resistance mutations, according to GSK. Aside from Jideytro and neladalkib, GSK gained a third NSCLC drug candidate from Nuvalent dubbed NVL-330. The asset is in early-stage development for HER2-altered NSCLC, with enrollment currently ongoing for a Phase 1a/1b study, according to a federal trials database . The Nuvalent-acquired assets join GSK’s Hansoh Pharmaceutical–partnered antibody-drug conjugate (ADC) risvutatug rezetecan (ris-rez), which the collaborators are also advancing for NSCLC. Data from the Phase 3 ARTEMIS-008 trial earlier this month showed significantly better overall survival outcomes in patients on ris-rez versus standard of care. These findings have emboldened Hansoh to seek approval for ris-rez in China. GSK paid $185 million upfront in December 2023 for the license to develop and commercialize ris-rez outside of mainland China, Taiwan, Hong Kong and Macau. Up to $1.525 billion is on the line in milestones. Antibody-drug conjugates GSK and Hansoh’s ADC clinches late-stage win, teeing up regulatory submission in China GSK and Hansoh Pharmaceutical’s antibody-drug conjugate success validates their partnership, one of the many deals in which Big Pharma has tapped a China company for promising cancer candidates. July 10, 2026 · 1 min read · Gabrielle Masson Read more

In a landmark moment for its oncology ambitions, GSK has secured FDA approval for Jideytro (zidesamtinib) as the first commercial lung cancer drug in the company’s history. The milestone was made possible by GSK’s recent acquisition of Nuvalent for $10.6 billion. The approval for Jideytro comes just a week after the British pharma closed the deal and about two months ahead of the FDA’s target decision date of Sept. 18. The green light allows Jideytro to treat adult patients with advanced ROS1-positive non-small cell lung cancer who received a prior ROS1 inhibitor. “The rapid progression of Jideytro from development to approval reflects both the strength of the underlying science and the urgent need for additional effective and tolerable treatments for ROS1-positive lung cancer,” GSK’s chief scientific officer, Tony Wood, said in a July 22 statement. By GSK’s estimate, about 50,000 new cases of ROS1-positive NSCLC are diagnosed each year worldwide, mostly among non-smokers in their 40s and 50s who could stay on treatment for several years. GSK has suggested that Jideytro holds “multi-blockbuster potential,” an ambitious projection considering none of the existing ROS1 NSCLC drugs—by Pfizer, Roche, Bristol Myers Squibb and most recently, Nuvation Bio—have come close to that target. Jideytro differentiates itself from earlier therapies such as Pfizer’s Xalkori and BMS’ Augtyro through its unique molecular design. Nuvalent designed Jideytro to overcome treatment-emergent ROS1 mutations while sparing the structurally related TRK family, thereby preventing off-target toxicities. It features robust central nervous system penetration to tackle brain metastases, a common complication in ROS1-positive NSCLC. In the single-arm Arros-1 phase 1/2 clinical trial, Jideytro booked an objective response rate of 44% in 117 patients with ROS1 inhibitor-pretreated NSCLC. In terms of duration of response, 82% and 69% of responders remained in remission at six months and 12 months, respectively. Among 50 patients who had measurable brain metastases, responses were observed in 48% of patients, including 22% with a complete response, according to the drug’s label. A 50% ORR rate was also recorded in the 42 patients who had ROS1 resistance mutations. Despite the strong data, GSK has a long ways to go before Jideytro could reach blockbuster status. One of its primary competitors is Ibtrozi (taletrectinib) by David Hung’s Nuvation Bio. Following a line-agnostic FDA nod for ROS1-positive NSCLC in June 2025, Ibtrozi—which also features intracranial activity and TRK sparing— generated $18.5 million during the first quarter of 2026. The current Jideytro label only allows the GSK drug to be used in patients who received a prior ROS1 inhibitor. Responding to a Fierce inquiry, a GSK spokesperson pointed to Nuvalent’s previous comment that it would seek a first-line label expansion this year. At the 2026 American Society of Clinical Oncology annual meeting, Nuvalent also reported promising preliminary data for zidesamtinib in non-NSCLC solid tumors, indicating the drug may hold pan-tumor potential with a 40% ORR across 10 tumor types. Jideytro is the first product emerging from GSK’s Nuvalent acquisition. Neladalkib, a fourth-generation ALK inhibitor, could be next with an FDA target action date of Nov. 27, 2026, for advanced ALK-positive NSCLC. GSK has floated multi-blockbuster hopes for that drug, too. Beyond the Nuvalent assets, GSK is advancing risvutatug rezetecan (ris-rez), a B7-H3-targeted antibody-drug conjugate, in a phase 3 extensive-stage small-cell lung cancer study. The drug’s original developer, Hansoh Pharma, just reported a phase 3 win in SCLC in China.